The following data is part of a premarket notification filed by Z-medica, Llc with the FDA for Quikclot Radial.
| Device ID | K181641 |
| 510k Number | K181641 |
| Device Name: | QuikClot Radial |
| Classification | Dressing, Wound, Drug |
| Applicant | Z-Medica, LLC 4 Fairfield Boulevard Wallingford, CT 06492 |
| Contact | Sheila K. Wallin |
| Correspondent | Yarmela Pavlovic Hogan Lovells U.S. LLP 3 Embarcadero Center Suite 1500 San Francisco, CA 94111 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-21 |
| Decision Date | 2018-12-24 |
| Summary: | summary |